The IVD Directive was published in the Official Journal in its final
form on 7 December 1998.
I am informed that the full text is available for download free of
charge at present, BUT only for 20 days - presumably till 26 December
so hurry if you want a copy!
In summary:
1. EQA specimens and CRMs are EXCLUDED from the scope ('Whereas'
clause 9), while calibration and control materials are included
2. Annex II (devices for which third party verification is required)
includes:
List A - blood grouping (ABO, Rh, Kell), HIV (1, 2), hepatitis (B, C, D)
List B - glucose self-test, PSA, PKU, Downs risk, HLA (DR, A, B),
infection (rubella, toxo, CMV, chlamydia), blood grouping (Duffy,
Kidd, anti-RBC)
Web site details and instructions (courtesy of EDMA):
http://europa.eu.int/eur-lex/en/oj/index.html
select issues of 07/12/98
issue L331, document nr. 98/79/EC
I hope this is helpful.
Dr David Bullock
Director, Wolfson EQA Laboratory
P O Box 3909, Birmingham B15 2UE, U K
FAX: 0121 414 1179
Phone: 0121 414 7300
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